Process Engineer

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Location: London (flexible working with 1-2 days minimum in office)

Salary: £40-50k + equity options

Full-time, permanent contract

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RBW Consulting have exclusively partnered with a medtech start-up with a genuinely disruptive product, aiming to revolutionise lifesaving treatment through a portable, wearable medical device.

We are seeking a practical, talented Process Engineer to play a key role in the development, improvement and scale-up of a robust production system for our novel medical device.

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Initially, you will play key role in supporting an ongoing design transfer to manufacture project. Following this, you will be responsible for ensuring the development, implementation and maintenance of manufacturing processes while adhering to ISO 13485 quality standards. You will play an integral role in ensuring product quality for the launch and scale-up of a new lifesaving medical device.

The ideal candidate should possess a strong background in process engineering with knowledge and experience of quality management systems within the medical device industry.

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Process Engineer Key Responsibilities:

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Process Implementation & Improvement:

- Conduct and report on process validations: IQ, OQ and PQ.

- Collaborate with cross-functional teams to analyse and enhance manufacturing, assembly and QC processes.

- Lead the CPI programme to identify and implement appropriate strategies and solutions for process optimisation, cost reduction and efficiency improvement.

- Develop and maintain process documentation including standard operating procedures (SOPs), manufacturing work instructions and process flowcharts.

- Assist with Design for Manufacture (DFM) for continuous improvement.

- Managing / supporting the relationships within our supply chain.

- Identify, evaluate and monitor potential international supply chain partners.

- Devise and conduct training programs with production partners on production processes and quality procedures.

Quality Management:

- Support the maintenance of an effective quality management system compliant to ISO 13485 and 21 CFR Part 820.

- Perform risk assessments, root cause analyses and corrective/preventive actions (CAPA) to address quality issues and non-conformances.

- Drive continuous improvement initiatives to enhance product quality, reduce defects and increase customer satisfaction.

Process Engineer Ideal Qualifications and Requirements:

- Bachelor's degree in Engineering or a related field (e.g. Mechanical, Industrial, Biomedical Engineering).

- 3+ years of experience in process engineering, quality engineering or a related role within the medical device industry.

- Hands on experience of process validation (IQ, OQ and PQ).

- Strong knowledge of quality management systems, regulatory requirements (e.g. ISO 13485, FDA) and standards relevant to medical devices.

- Proficiency in using quality tools such as Failure Modes and Effects Analysis (FMEA), Statistical Process Control (SPC) and Root Cause Analysis (RCA).

- Experience with process validation, statistical analysis and problem-solving methodologies. - Hands-on experience in a variety of industrial manufacturing processes.

Process Engineer Key Skills:

- Excellent analytical, problem solving and decision making skills.

- Strong communication and collaboration abilities to work effectively across cross-functional teams.

- Motivation to grow and evolve with a small dynamic early-stage start-up.

Why this role?

- Competitive salary & equity options.

- Hybrid working model with flexible hours.

- International travel opportunities.

- Opportunity to contribute significantly to the development and implementation of a lifesaving medical device.

- Exposure to a dynamic start-up environment that values innovation and collaboration. Mentorship from experienced engineers and the chance to grow your skills and career.

- Definitive pathway for progression within the company.

Apply today to join a dynamic and innovative team, and play a key role in the development of a life-saving medical device.

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